Method and apparatus for mounting a data transmission device in a communication system

ABSTRACT

Method and apparatus for mounting a data transmission device in a communication system including and adhesive pad with pull tab and raised border portions is provided. The adhesive pad may also include a flexible band to fit around the patient&#39;s arm to firmly secure the adhesive pad onto the patient&#39;s skin. The flexible band is size adjustable. The pull tab and raised borders on the adhesive pad permit easy single handed application and removal process of the adhesive pad by the patient.

BACKGROUND

The present invention relates to data monitoring and detection systems.More specifically, the present invention relates to method and apparatusfor adhering and/or removing a data transmission unit to and/or from apatient's skin used in data communication systems such as a datatransmitter unit in continuous glucose monitoring systems.

Continuous glucose monitoring systems generally include a sensor such asa subcutaneous analyte sensor for detecting analyte levels such as bloodglucose levels, a transmitter (such as an RF transmitter) incommunication with the sensor and configured to receive the sensorsignals and to transmit them to a corresponding receiver unit by forexample, using RF data transmission protocol. The receiver may beoperatively coupled to a blood glucose monitor that performs bloodglucose related calculations and data analysis.

The transmitter may be mounted or adhered to the skin of a patient andalso in signal communication with the sensor a portion of which may beimplanted into the skin of the patient. Generally, the sensor isconfigured to detect and measure the blood glucose levels of the patientover a predetermined period of time, and the transmitter is configuredto transmit the measured blood glucose levels over the predeterminedperiod of time for further analysis. Given this, it is important thatthe transmitter be securely fastened or adhered to the skin of thepatient over the predetermined period of time. In one example,continuous glucose monitoring system may employ a transmitter mounted onthe skin of a patient to detect blood glucose levels over several days.

In view of the foregoing, it would be desirable to have method andapparatus which would provide secure and long lasting adherence to theskin of the patient over the predetermined period of time so as toensure that the transmitter is substantially maintained in a relativelyfixed position on the patient's skin during the time period of the bloodglucose measurements by the sensor. Also, it would be desirable to havea method and apparatus to remove the transmitter mounted on thepatient's skin with ease and relative little pain to the patient.

SUMMARY OF THE INVENTION

In one embodiment, a pull tab section is provided to the adhesive pad onthe transmitter mount so as to provide easy, fast and relativelypainless removal of the transmitter attached to the skin of the patient.The pull tab section also provides a one-hand removal of the transmitterfrom the patient's skin.

In a further embodiment of the present invention, a flexible band isprovided to the adhesive pad on the transmitter mount to securely fastenthe transmitter onto the patient's skin around, for example, the arm orthe leg. The flexibility of the band provides elasticity with the skinmovement so that the transmitter does not detach from the patient's skinduring the predetermined time period of blood glucose measurementsespecially in the case of the patient engaging in strenuous activities.The flexible band is also configured to provide adjustability in lengthso that it may easily adapt to varying sizes.

In another embodiment of the present invention, a breathable thinmaterial such as foam or film is provided substantially around the outerperiphery of the adhesive pad as raised border portions to provide addedrigidity of the transmitter mounted to the patient's skin. Moreover, ina further embodiment of the present invention, the raised borderportions may include gaps portions along the outer periphery of theadhesive pad, while the adhesive pad is integrated with the pull tab sothat the patient may easily apply and remove the adhesive pad onto andfrom the patient's skin.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an adhesive pad with a pull tab in accordance withone embodiment of the present invention;

FIG. 2 illustrates a perspective view of the adhesive pad with a pulltab shown in FIG. 1;

FIG. 3 illustrates the adhesive pad with the pull tab mounted onto apatient's skin prior to removal in accordance with one embodiment;

FIG. 4 illustrates the adhesive pad with the pull tab in operation toremove the adhesive pad from the patient's skin in accordance with oneembodiment of the present invention;

FIG. 5 illustrates the adhesive pad with the pull tab in operation toremove the adhesive pad from the patient's skin without the mount inaccordance with one embodiment of the present invention;

FIG. 6 illustrates the adhesive pad with the pull tab mounted on thepatient's skin and the pull tap in operation in accordance with oneembodiment of the present invention;

FIG. 7 illustrates an alternate view of the adhesive pad with the pulltab mounted on the patient's skin and the pull tap in operation as shownin FIG. 6;

FIG. 8 illustrates an adhesive pad with a flexible band in accordancewith one embodiment of the present invention;

FIG. 9 illustrates a perspective view of the adhesive pad with flexibleband shown in FIG. 8;

FIG. 10 illustrates the adhesive pad with flexible band shown in FIG. 8including the mount attached to the adhesive pad in accordance with oneembodiment of the present invention;

FIG. 11 illustrates the adhesive pad with flexible band deployed arounda patient's arm in accordance with one embodiment of the presentinvention;

FIG. 12 illustrates a perspective view of the adhesive pad with flexibleband deployed around a patient's arm shown in FIG. 11;

FIG. 13 illustrates an adhesive pad with raised border portion inaccordance with one embodiment of the present invention;

FIG. 14 illustrates a perspective view of the adhesive pad with raisedborder portion shown in FIG. 13;

FIG. 15 illustrates an adhesive pad with a pull tab and raised borderportions in accordance with one embodiment of the present invention; and

FIG. 16 illustrates a perspective view of the adhesive pad with the pulltab and raised border portions shown in FIG. 15.

DETAILED DESCRIPTION

FIG. 1 illustrates an adhesive pad with a pull tab in accordance withone embodiment of the present invention. Referring to the Figure, anadhesive pad 110 is provided for attaching a mount 130 such as atransmitter in a data monitoring system such as a continuous glucosemonitoring system. As can be seen from the Figure, the mount 130 isprovided on the top surface of the adhesive pad 110, and may be fixedlyretained thereon. In one embodiment such as for use in the continuousglucose monitoring system, the transmitter is provided so as to engageonto the mount 130 to firmly position the transmitter on the adhesivepad 110, and ultimately on the skin of a patient. The transmitter isthen in communication with a sensor that is configured to measureanalyte levels of the patient such as blood glucose levels. The adhesivepad 110 in one embodiment may be provided with adhesive material on thebottom surface so as to readily attach onto the patient's skin. Morespecifically, the adhesive pad 110 in one embodiment may comprise astretchable, flexible thin film with adhesive material provided on thebottom surface.

Referring back to FIG. 1, also shown is a pull tab 120 which in oneembodiment may be molded onto the adhesive pad 110. The pull tab 120 inone embodiment may alternatively be laminated onto the adhesive pad 110or may be coupled to the adhesive pad 110 using other types ofconnections so as to provide a firm and secure connection to theadhesive pad 110. As discussed in further detail below, in accordancewith one embodiment of the present invention, the pull tab 120 may beintegrated with the conformable substrate of the adhesive pad 110 topermit the patient to stretch deform the adhesive pad 110 so that edgesof the adhesive pad 110 attached to the patient's skin is liftedtherefrom, thus assisting in the removal process of the adhesive pad110.

FIG. 2 illustrates a perspective view of the adhesive pad 110 with thepull tab 120 shown in FIG. 1. FIG. 3 illustrates the adhesive pad 110with the pull tab 120 mounted onto the patient's skin prior to removalin accordance with one embodiment. Referring to FIG. 3, it can be seenthat the bottom surface of the adhesive pad 110 including the adhesivematerial is in substantial complete contact with the skin 310 of thepatient's arm.

FIG. 4 illustrates the adhesive pad with the pull tab in operation toremove the adhesive pad from the patient's skin in accordance with oneembodiment of the present invention. Referring to the Figure, when thepatient wishes to remove the adhesive pad 110 from the patient's skin,in one embodiment, the patient may pull the pull tab 120 in thedirection shown by arrow A. In response to the patient's pulling thepull tab 120 in the direction shown by arrow A, the edges of theadhesive pad 110 lifts from the skin of the patient, and as shown inFIG. 4, the portions of the adhesive pad 110 begins to responsivelydeform in the direction shown by arrows B, thus effectively beginning tolift the adhesive pad 110 from the patient's skin during the removalprocess. Accordingly, the mount 130 attached to the top surface of theadhesive pad 110 is removed from the patient along with the removal ofthe adhesive pad 110. In this manner, in accordance with one embodimentof the present invention, the integrated pull tab 120 with the adhesivepad 110 allows the mount 130 to be securely fastened onto the patient'sskin for extended periods of time, and also allows gentle and relativelypainless and easy removal of the mount 130 after use. In the case ofcontinuous glucose monitoring systems, the transmitter may be coupled tothe mount 130 during the transmission period which may extend overseveral days. Upon completing the analyte measurements and transmissionby the transmitter, the transmitter coupled to the mount 130 may beeasily and relatively painlessly removed from the patient's skin by theoperation of the pull tab 120.

FIG. 5 illustrates the adhesive pad 110 with the pull tab 120 inoperation to remove the adhesive pad 110 from the patient's skin withoutthe mount 130 in accordance with one embodiment of the presentinvention. FIG. 6 illustrates the adhesive pad 110 with the pull tab 120mounted on the patient's skin and the pull tap 120 in operation inaccordance with one embodiment of the present invention. FIG. 7illustrates an alternate view of the adhesive pad 110 with the pull tab120 mounted on the patient's skin and the pull tap 120 in operation asshown in FIG. 6.

In this manner, in accordance with the various embodiments of thepresent invention, during the removal process of the adhesive pad 110from the patient's skin, the pull tab 120 integrated with the adhesivepad 110 allows the patient to remove the adhesive pad 110 by stretchingthe adhesive pad 110 so that the adhesive pad 110 is deformed and suchdeformation begins to lift the adhesive pad 110 away from the skin.

In one embodiment, the pull tab 120 may be operated by the patient usingonly one hand so that it provides an easy and relatively painlessremoval process for the patient. Furthermore, in one embodiment, themount 130 may provide some rigidity to the adhesive pad 110 so as tofunction as a strain relief such that when the patient pulls the pulltab 120 during the removal process, the weaker bonded area of theadhesive pad 110 (for example, the edge portions of the adhesive pad110) may stretch in response thereto, thus lifting off of the patient'sskin first. The pull tab 120 in one embodiment may be made of substratematerial similar to the material of the adhesive pad 110, but which isfurther reinforced to allow material deflection when the pull tab 120 ispulled by the patient.

FIG. 8 illustrates an adhesive pad with a flexible band in accordancewith one embodiment of the present invention. Referring to the Figure,there is provided an adhesive pad 840 configured to attach a mount (notshown) for mounting, for example, a transmitter mount to be placed on apatient's skin. Also shown in FIG. 8 is a flexible band 820 having afirst end 850 that is fixedly attached to the adhesive pad 840 as shownin the Figure, and a second end 830 that is configured for sizeadjustment when placing the adhesive pad 840 for deployment on thepatient's skin. Also shown in FIG. 8 is a release liner 810 that isdisposed substantially on the bottom surface of the adhesive pad 840.The release liner 840 may be removed by a single hand operation toexpose the adhesive bottom surface of the adhesive pad 840 substantiallyimmediately prior to attaching the adhesive pad 840 onto the patient'sskin.

In one embodiment, the flexible band 820 may be made of the samesubstrate material as the adhesive pad 840, or alternatively may bethicker than the adhesive pad 840 to provide additional rigidity. Morespecifically, in one embodiment, the flexible band 820 may comprise aflexible elastomeric substrate which provides the desired elasticity aswell as flexibility as well as rigidity for support.

In one embodiment, the first end 850 of the flexible band 820 may beintegrated with the adhesive pad 840 during the manufacturing process sothat the flexible band 820 and the adhesive pad 840 may comprise single,integrated material. In one embodiment, the second end 830 of theflexible band 820 may be provided with adhesive on the bottom surface sothat when the adhesive pad 840 is positioned on the patient's skin ofthe arm, for example, the patient may wrap around the flexible band 820around the patient's arm and adjust the length of the flexible band 840to fit around the patient's arm. More specifically, the second end 830of the flexible band 820 may incorporate a predetermined adhesivesection which is configured to attach to the adhesive pad 840 as shownin FIG. 8. Thereafter, the excess portion of the second end 830 of theflexible band 820 may be detached and discarded.

FIG. 9 illustrates a perspective view of the adhesive pad 840 withflexible band 820 shown in FIG. 8. FIG. 10 illustrates the adhesive pad840 with flexible band 820 shown in FIG. 8 including the mount 1010attached to the adhesive pad 840 in accordance with one embodiment ofthe present invention. FIG. 11 illustrates the adhesive pad 840 withflexible band 820 deployed around a patient's arm 1110 in accordancewith one embodiment of the present invention, and FIG. 12 illustrates aperspective view of the adhesive pad 840 with flexible band 820 deployedaround a patient's arm 1110 shown in FIG. 11.

In this manner, in accordance with the various embodiments of thepresent invention, the flexible band 820 may be configured to wrapsubstantially around the location of the patient's skin so that itprovides additional and secure placement of the adhesive pad 840 duringthe time that the patient is wearing the adhesive pad on the patient'sskin. Furthermore, as discussed above, the flexible band 820 is providedwith size adjustment capability so that it may be configured to fitaround varying sizes of patients' arms and the like. Moreover, in themanner described above, the application of the adhesive pad 840 onto thepatient's skin may be performed with one hand, and further, the removalprocess of the adhesive pad 840 may also be performed with one had, thusproviding ease of use to the patients. Furthermore, in this manner, theflexible band 820 may replace the need for an over-bandage for theadhesive pad 840 once attached to the patient's skin for protection forthe patients who tend to be more physically active.

FIG. 13 illustrates an adhesive pad with raised border in accordancewith one embodiment of the present invention. As can be seen from theFigure, there is provided a raised border portion 1310 substantiallyaround the outer edge of the adhesive pad 840. Also shown in the releaseliner 810 that is configured to protect the adhesive side of theadhesive pad 840, and which is to be removed just prior to theapplication of the adhesive pad 840 onto the patient's skin. Referringto FIG. 13, the raised border portion 1310 is configured to providestability when the release liner 810 is removed from the bottom surfaceof the adhesive pad 840 prior to deploying the adhesive pad 840 onto thepatient's skin.

In one embodiment, the raised border portion 1310 is substantiallywater-proof, highly conformable to the varying curvature of thepatient's skin, and breathable. Some examples of such material includeIV3000 by Smith & Nephew, Tegaderm by 3M Corporation, and Transeal byDeRoyal or any conformable material which may be used for wound care andclosure. In one embodiment, the raised border portion 1310 may includean adhesive coated polyolefin foam ring (available from 3M Corporationor Scapa Medical) bonded to the top of a carrier material such asbreathable film or the material comprising the adhesive pad 840. In thismanner, when the release liner 810 is removed, there is providedsufficient rigidity to maintain conformity at the time of applicationonto the patient's skin, and acceptable moisture vapor transmission rate(MVTR) (for example, a minimum requirement of 400 g/m²/24 hours) suchthat the adhesive pad 840 with the raised border portion 1310 isconfigured to remain attached to the patient's skin while allowingmoisture to travel therethrough for extended periods of time. Suchbreathable material attached to the patient's skin provides foradditional comfort especially given the duration of the attachment tothe patient's skin as it provides porosity to the moisture from the skinand allows evaporation.

FIG. 14 illustrates a perspective view of the adhesive pad 840 with theraised border portion 1310 shown in FIG. 13. In accordance with oneembodiment and referring to FIGS. 13-14, the patient may remove or peeloff the release liner 810, and using one hand, easily apply the adhesivepad 840 on the patient's skin. The raised border portion 1310 in oneembodiment is configured to retain the rigidity of the adhesive pad 840such that application of the adhesive pad 840 with one had onto thepatient's skin can be readily achieved. As discussed above, the raisedborder portion 1310 may comprise a breathable thin film which providesfor additional comfort to the patient when the adhesive pad 840 isapplied on the patient's skin over an extended period of time.

FIG. 15 illustrates an adhesive pad with a pull tab and raised borderportions in accordance with one embodiment of the present invention.FIG. 16 illustrates a perspective view of the adhesive pad with the pulltab and raised border portions shown in FIG. 15. Referring to FIGS.15-16, there is provided a pull tab 120 attached to an adhesive pad 110,both of which are substantially similar in composition and configurationas discussed above in conjunction with FIGS. 1-7. Accordingly, adetailed description of the pull tab 120 and the adhesive pad 110 isomitted herein, but the description and operation discussed above isequally applicable in this embodiment.

In the embodiment of the present invention shown in FIGS. 15-16, thereis also provided raised border portions 1510 substantially around theedge portion of the adhesive pad 110. However, in this embodiment, ascan be seen from the Figures, the raised border portions include gapportions 1520 which separate the two raised border portions 1510. Thegap portions 1520 permit the operations of the pull tab 120 during theremoval process of the adhesive pad 110 so that the rigidity of theraised border portions 1510 do not substantially interfere with theremoval process by the use of the pull tab 120.

In this manner, in accordance with one embodiment of the presentinvention, the raised border portions 1510 may be configured to providestructure and rigidity to the thin adhesive pad 110 when the patient isattaching the adhesive pad 110 onto the patient's skin, allowing onehand application operation, and further, the gap portions 1520 in theraised border portions 1510 substantially do not interfere with theoperation of the pull tab 120 during the removal process of the adhesivepad 110 from the patient's skin. As such, in one embodiment, the patientmay be provided with an easy to use, single handed application andremoval approach to affixing the adhesive pad 110 onto the patient'sskin as well as removal thereof.

In the manner described above, in accordance with various embodiments ofthe present invention, there is provided an apparatus for mountingand/or removing a device to and/or from a surface, the apparatuscomprising an adhesive pad for attaching to a surface, and a pull tabportion mounted to the adhesive pad, the pull tab portion configured todeform the adhesive pad to detach a portion thereof from the surface.

In one embodiment, the adhesive pad may include an upper side and alower side, the lower side configured to attach to the surface, andfurther, where the upper side is configured to attach to a device.

Also, the device in one embodiment may include an RF transmitter.

In a further embodiment, the surface may include a skin of a patient,and further, wherein the adhesive pad is substantially elastomeric.Moreover, the pull tab portion may be relatively thicker than theadhesive pad.

In another embodiment, there is also provided a film layer substantiallyaround the outer periphery of the adhesive pad, the firm layer includingat least one gap along the outer periphery of the adhesive pad. The filmlayer may be substantially water resistant. Also, the film layer may besubstantially breathable.

In a further embodiment, the adhesive pad and the pull tab portion maybe disposable.

In accordance with another embodiment of the present invention, there isprovided an apparatus for mounting a device to a surface, comprising anadhesive pad for attaching to a surface, and a flexible band having afirst end and a second end, the first end fixedly mounted to theadhesive pad, where the second end of the flexible band is configured tosubstantially attach to the adhesive pad.

In one aspect of the present invention, the length of the flexible bandmay be adjustable.

In yet a further embodiment there may be provided a release linerattached to the adhesive pad, where the release liner is configured todetach from the adhesive pad before the adhesive pad is attached to thesurface. Further, the adhesive pad ay be configured to substantiallyfixedly positioned on said surface for a predetermined period of time,where the predetermined period of time may include one of 12 hours, 24hours, 36 hours, 48 hours, 60 hours, and 72 hours.

Also, the adhesive pad and the flexible band may be disposable.

An apparatus for mounting and/or removing a device to and/or from asurface in accordance with yet another embodiment includes an adhesivepad for attaching to a surface, and a film layer provided substantiallyaround the outer periphery of the adhesive pad, the film layerconfigured to substantially retain the shape of the adhesive pad.

The film layer may be substantially water proof, and further, theadhesive pad may be substantially conformable to the surface, where thesurface may include the skin of a patient.

Also, the adhesive pad may be configured to substantially conformablyattached to the contour of the skin, and further, the adhesive pad andthe film layer may be disposable.

Various other modifications and alterations in the structure and methodof operation of this invention will be apparent to those skilled in theart without departing from the scope and spirit of the invention.Although the invention has been described in connection with specificpreferred embodiments, it should be understood that the invention asclaimed should not be unduly limited to such specific embodiments. It isintended that the following claims define the scope of the presentinvention and that structures and methods within the scope of theseclaims and their equivalents be covered thereby.

1. An apparatus comprising: an adhesive pad for attaching to a skinsurface; and a pull tab portion integral to the adhesive pad, the pulltab portion configured to deform the adhesive pad to detach a portionthereof from the skin surface; wherein the adhesive pad deforms in afirst direction when a predetermined force is applied to the pull tabportion in a second direction.
 2. The apparatus of claim 1 wherein theadhesive pad includes an upper side and a lower side, the lower sideconfigured to attach to the surface, and further, wherein the upper sideis configured to attach to a device.
 3. The apparatus of claim 2 whereinthe upper side of the adhesive pad maintains the device at asubstantially fixed position relative to the surface.
 4. The apparatusof claim 1 wherein the adhesive pad is substantially elastomeric.
 5. Theapparatus of claim 1 wherein the pull tab portion is relatively thickerthan the adhesive pad.
 6. The apparatus of claim 1 further including afilm layer provided substantially around an outer periphery of theadhesive pad, the film layer including at least one gap along the outerperiphery of the adhesive pad.
 7. The apparatus of claim 6 wherein thefilm layer is substantially water resistant.
 8. The apparatus of claim 6wherein the film layer is substantially breathable.
 9. The apparatus ofclaim 1 wherein the adhesive pad and the pull tab portion aredisposable.
 10. An apparatus, comprising; an adhesive pad for attachingto a skin surface; and a flexible band having a first end and a secondend, the first end fixedly mounted to the adhesive pad; wherein thesecond end of the flexible band is configured to substantially attach tothe adhesive pad; and further wherein the adhesive pad includes a pulltab portion, the adhesive pad forming in a first direction when apredetermined force is applied to the pull tab portion in a seconddirection.
 11. The apparatus of claim 10 wherein the length of theflexible band is adjustable.
 12. The apparatus of claim 10 furtherincluding a release liner attached to the adhesive pad, wherein therelease liner is configured to detach from the adhesive pad before theadhesive pad is attached to the surface.
 13. The apparatus of claim 10wherein the adhesive pad is fixedly positioned on said surface for apredetermined period of time.
 14. The apparatus of claim 13 wherein thepredetermined period of time includes one of 12 hours, 24 hours, 36hours, 48 hours, 60 hours, and 72 hours.
 15. The apparatus of claim 10wherein the adhesive pad and the flexible band are disposable.
 16. Anapparatus comprising: an adhesive pad for attaching to a surface; and afilm layer provided substantially around an outer periphery of theadhesive pad, the film layer configured to substantially retain theshape of the adhesive pad; wherein the adhesive pad includes a pull tabportion, the adhesive pad deforming in a first direction when apredetermined force is applied to the pull tab portion in a seconddirection.
 17. The apparatus of claim 16 wherein the film layer issubstantially water proof, and further, wherein the adhesive pad issubstantially conformable to the surface.
 18. The apparatus of claim 16wherein the surface includes a skin of a patient.
 19. The apparatus ofclaim 18 wherein the adhesive pad is conformably attached to the contourof the skin.
 20. The apparatus of claim 16 wherein the adhesive pad andthe film layer are disposable.
 21. The apparatus of claim 1 wherein thefirst direction is different from the second direction, and furtherwherein the second direction is substantially away from the adhesivepad.
 22. The apparatus of claim 10 wherein the first direction isdifferent from the second direction, and further wherein the seconddirection is substantially away from the adhesive pad.
 23. The apparatusof claim 16 wherein the first direction is different from the seconddirection, and further wherein the second direction is substantiallyaway from the adhesive pad.